510(k) K191091 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Rampart One Lumbar Interbody Fusion System
| Applicant | Spineology, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, May 23, 2019 |
| Received | Apr 24, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191091
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.